D - Statement of Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Service Maintenance and Support for Philips MR7700 3T MRI Scanner and Chiller

Statement of Need and Purpose:

The goal of this procurement is to obtain a comprehensive service contract covering preventive maintenance, routine upgrades and remedial service for the National Institute on Aging (NIA)’s Philips 3T MR7700 MRI scanner and its associated system chiller, located at Medstar Harbor Hospital in Baltimore, MD. This is existing government-owned laboratory equipment previously purchased from Philips Healthcare.

Background Information and Objective:

The Laboratory of Clinical Investigation at the NIA operates the Clinical Unit at Harbor Hospital using a Philips 3T MR7700 MRI scanner to conduct studies on human subjects under NIA Clinical Trial protocols. As a FDA-certified clinical diagnostic device, there are strict maintenance and quality control requirements for the continued operation of this scanner. Due to the restricted availability of replacement and upgrade parts, software, diagnostic tools and factory-trained technicians, this maintenance must be carried out by authorized Original Equipment Manufacturer (OEM) certified factory-trained technicians.

In addition to providing comprehensive support for the scanner itself, including the MRI magnet, gradient and shim coils, console electronics and radio-frequency coils, the contract will cover the KKT cBoxX 100 chiller that provides cooling water to the magnet’s cold head refrigeration system, gradient coil and gradient amplifier. Maintenance on this ancillary equipment must meet Philips’ specifications since the combination of the scanner and chiller as an integrated system must maintain certification for continued clinical use.

The MR7700 MRI scanner is used heavily and must be kept in operation with minimal downtime. Thus, rapid availability of replacement parts and factory-trained technicians to diagnose and remedy any functional problems is essential.

Period of Performance:

Base Year: 2/21/2025-2/20/2026 *Please note that the base period for the chiller is 2/27/2025-2/20/2026 Option Year 1: 2/21/2026-2/20/2027 Option Year 2: 2/21/2027-2/20/2028 Option Year 3: 2/21/2028-2/20/2029 Option Year 4: 2/21/2029-2/20/2030

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities not otherwise provided by the Government as needed to perform preventative maintenance and remedial repair for the Philips MR7700 3T MRI scanner (site #105062860) and its associated KKT cBoxX100 chiller (site #88406191).

The contractor shall provide on-site maintenance and repair service at Harbor Hospital that includes the following provisions: (1) planned preventive maintenance inspection, which involves equipment inspection, problem troubleshooting, installation of software updates or enhancements as necessary, and training government staff, as needed; (2) Emergency or per-call repair services, (3) Testing instruments and supplies; (4) Original Equipment Manufacturer (OEM) certified factory-trained technicians; and (5) all labor, replacement parts, and travel expenses. The MRI scanner is in the Gruehn Building (attached to Harbor Hospital Building), room number GNM 32, while the chiller is on the Hospital grounds just outside the 3T MRI building.

Specifically, Contractor shall perform planned Preventive Maintenance (PM) visits for equipment maintenance services during standard hours of coverage and scheduled at a mutually agreeable time with the designated COR or a COR-delegated official. Onsite preventive maintenance on the 3T MRI will include support on the chiller from 8:00 am-9:00 pm Monday through Friday.

Contractor shall provide Remote Proactive Monitoring (RPM) of subject instrumentation via an authorized Philips Remote Services network. RPM includes assessing magnet life support conditions (cryogen levels, cold head operation) so that service personnel and the NIA POC can be notified remotely prior to any degradation in magnet performance.

Contractor must have access to proprietary parts and test instrumentation for effective repair in case of malfunction. Technical performance requirements include system coverage on the subject equipment by Original Equipment Manufacturer (OEM) factory-trained, authorized technicians. In addition, any required parts and software or proprietary diagnostic tools and software enhancements must be OEM-certified and compatible with the subject equipment.

Service will include labor and parts coverage, extended coverage hours as noted in paragraphs above, on-site labor response, technical telephone response (call-back to schedule), and planned maintenance, extended planned maintenance coverage hours, diagnostic software license and service documentation, user training, and preferred labor rate. A Project manager or service manager is required, who will be the main point of contact for the contractor. The project or service manager will receive service calls, schedule preventative maintenance and dispatch the service technicians.

Important: Due to the heavy workload on the scanner and the need to maintain FDA certification for scanning human subjects, the contractor must ensure the following:

1.The contractor must have either an adequate supply of parts in stock and readily available to the service technicians or be able to obtain any required part within 24 hours of the service technician’s request.

2.The service technicians need to be Philips (OEM) trained and certified.

3. All service must be warranted for 6 months and any replacement part must have at least a 12 month warranty.

GOVERNMENT RESPONSIBILITIES

The government point of contact (POC) will make all necessary service calls as agreed to by the Government and the contractor. The POC will ensure that the service technicians have access to the site of the covered equipment as required.

Place of Performance:

National Institutes of Health (NIH) National Institute of Aging (NIA) Intramural Research Program (IRP) Medstar Harbor Hospital NIA Clinical Unit 3001 S Hanover St Baltimore, MD 21225

DELIVERY OR DELIVERABLES

The contractor shall deliver OEM-certified replacement parts, service equipment, software upgrades and diagnostic tools to the place of performance specified above as needed for preventive and remedial maintenance of the MRI scanner and chiller. Shipment of these items shall be arranged by the contractor at the contractor’s expense. The Government POC or delegated representative will coordinate with the contractor to ensure proper delivery to the instrument site.

REPORTING REQUIREMENTS

The service technician shall present a service ticket that briefly details the work performed during the service visit to the POC for signature and a copy of the ticket is to be left with the POC. Electronic delivery and signature of this documentation is acceptable.

A detailed written report of any service and\or preventative maintenance shall be submitted to the Contracting Officer’s Representative, or a delegated entity, within 1 month of service being performed.

OTHER CONSIDERATIONS

Travel:

All arrangements and expenses for travel by the contractor’s technicians and training staff needed to support the covered equipment will be the responsibility of the contractor.

Data Rights:

Work performed under the proposed service contract is not anticipated to produce new intellectual property. This work will provide proprietary parts, software and diagnostic tools to the contractor’s technicians and will by necessity allow technicians to see data collected by NIA on human subjects, as described above. These data and intellectual property must be protected from being divulged to a third party without proper approval in advance.

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

No publications or publicity are anticipated to arise from the work performed under the proposed contract.

Confidentiality of Information:

In the course of maintaining the MRI scanner, the contractor’s service technicians will have access to identifiable data on study participants (PII/PMI). Service activities must avoid disclosure, alteration or loss of these data. When necessary for repair or replacement of the scanner workstation or its components or for major software modifications and upgrades, the contractor must back up these data to a secure location prior to erasing or wiring over any records.